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Cognitive Protective Effect of Newer Antidiabetic Drugs

Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05347459
Enrollment
100
Registered
2022-04-26
Start date
2022-03-02
Completion date
2023-12-31
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

The proposed study aims to: 1. Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria 2. Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients 3. Undertake a network analysis to elucidate the potential pathways linking the observed protective effects, if any, with the observed changes in inflammatory or metabolic parameters

Detailed description

The investigators propose to profile diabetic patients taking SGLT2 inhibitors and DPP-4 inhibitors using different parameters and compare them to others on more traditional anti-diabetic therapy. Regression and comparative statistics will be used to determine whether the targeted drug classes offer a benefit in terms of cognitive function. If a trend (or correlation) is determined, a bioinformatic approach will be adopted to perform a network analysis including the targets of these drug classes and pathways showing in datasets of the inflammatory or metabolic parameters altered by the drug. This network analysis is intended to provide further mechanistic insight into the pathways involved in the observed drug action. The patients targeted will be divided into the following groups: 1. Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors 2. Diabetic patients treated with metformin only This will be in addition to a group of healthy non-diabetic controls to serve as a baseline reference.

Interventions

DRUGDapagliflozin

usual and customary doses for type 2 diabetes management

DRUGEmpagliflozin

usual and customary doses for type 2 diabetes management

DRUGCanagliflozin

usual and customary doses for type 2 diabetes management

DRUGSitagliptin

usual and customary doses for type 2 diabetes management

DRUGSaxagliptin

usual and customary doses for type 2 diabetes management

DRUGLinagliptin

usual and customary doses for type 2 diabetes management

DRUGVildagliptin

usual and customary doses for type 2 diabetes management

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Type 2 Diabetic Patients * Age (≥50 Years) * Ability to understand and cooperate with study procedures

Exclusion criteria

* Diagnosed dementia * Use of possible or known cognition impairing drugs in the last three months

Design outcomes

Primary

MeasureTime frameDescription
Prevention of decline in cognitive function associated with type 2 diabetes1 YearSlowed reduction of the Montreal Cognitive Assessment Battery Score

Secondary

MeasureTime frameDescription
Better cognitive performance in the intervention group at baseline1 YearHigher Montreal Cognitive Assessment Battery Score

Other

MeasureTime frame
Reduced serum inflammatory markers in intervention group1 Year

Countries

Egypt

Contacts

Primary ContactShams T Osman, BPharm
s-shams.mostafa@alexu.edu.eg+201096900070
Backup ContactAhmed F El-Yazbi, PhD
ahmed.fawzy.aly@alexu.edu.eg+201155881772

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026